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The Sugar Water Operations Team Blog
Welcome to The Sugar Water Operations Team Blog, your go-to destination for insightful and engaging content for pharma, biotech and life sciences startups (and beyond). Read on to find helpful tips and strategies from "the operations team in the cubicle next door." With decades of experience, we want to help set you up for success on your drug development and approval journey. Never want to miss a post? Follow us on LinkedIn and sign up for our newsletter too!
Will Your BIMO Package Be a Rate-Limiting Factor?
If you're preparing a marketing application for FDA review—whether a New Drug Application (NDA), Biologics License Application (BLA), or...
May 13, 20253 min read
Common Submission Gaps and Risks That Can Derail Your IND or NDA
You've worked hard to bring your drug to the cusp of an IND or NDA filing. But even strong programs can stumble at the final mile — and...
May 6, 20253 min read
How to Perform a Submission Gap Analysis and Submission Risk Assessment For Your IND or NDA
If you're preparing a major FDA submission like an IND, NDA or BLA, you already know it's a monumental milestone. But before you hit...
Apr 29, 20253 min read
How Start-Up Biotechs Can Succeed in a Turbulent Market (and How SWOT Can Help)
It’s no secret: the current market landscape is tough for start-up pharma and biotech companies. FDA layoffs are threatening to slow down...
Apr 11, 20252 min read
How SOPs, Policies, Work Instructions, and Job Aids Keep Biotech Companies Running Smoothly
When it comes to maintaining compliance, efficiency, and consistency in a small pharma or biotech company, having the right documentation...
Mar 11, 20253 min read
Keeping Regulatory Operations on Track During Transitions: Why a Flexible Partner Beats a Temporary Hire
In the fast-moving world of pharma and biotech, transitions are inevitable. Whether due to medical leave, layoffs, or the unexpected...
Mar 5, 20252 min read
Top Five Microsoft Word Formatting Tips for Start-Up Biotechs
For many start-up biotech companies, Microsoft Word is the go-to tool for drafting regulatory documents, grant proposals, and internal...
Feb 7, 20253 min read
How to Motivate a Cross-Functional eCTD Team in Small or Start-Up Pharma Companies
Big FDA submissions, like an IND or NDA, are high-stakes, high-pressure projects. For small or start-up pharma and biotech companies, the...
Jan 31, 20252 min read
How to Manage a Cross-Functional eCTD Submission Team
For small pharma or biotech companies looking to submit their first big application, whether it’s an IND, NDA or BLA, it’s important to...
Jan 15, 20253 min read
The Importance of Regulatory Correspondence Tracking: Best Practices for Pharma Teams
In the highly regulated world of pharmaceuticals, keeping a meticulous record of regulatory correspondence isn’t just a good idea—it’s...
Dec 20, 20242 min read
Hidden Fees to Watch For When Working With a CRO
Partnering with a Contract Research Organization (CRO) is often essential for biotech and pharmaceutical companies navigating the...
Nov 20, 20243 min read
How to Apply for a Pre-Assigned Application Number
If you're ready to start submitting eCTD applications at the Pre-IND or IND stage -- or even getting ready to submit your NDA or BLA,...
Nov 15, 20243 min read
Navigating Pre-IND Submissions: A Guide for Small and Start-Up Pharma Companies
Preparing to submit an Investigational New Drug (IND) application is a critical step for small and start-up pharmaceutical companies...
Nov 6, 20243 min read
The Sugar Water Operations Team: ONE YEAR IN
As we celebrate one year in business for The Sugar Water Operations Team, check out our interview with CEO Carla Y. Griffin.
Nov 1, 20241 min read
Passing the Mark: The Three Different Levels of FDA Validation Errors
Understanding the differences between low, medium, and high validation errors in the FDA’s eCTD (electronic Common Technical Document)...
Oct 18, 20243 min read
Become a Submission Readiness Genius: How to Create FDA Compliant PDFs
Creating an FDA-compliant PDF document for regulatory submission is a critical step in ensuring that your submission is acceptable for...
Oct 11, 20244 min read
Streamline Your Time-Consuming Marketing Application Tasks
For biotech, pharma, and life sciences start-ups, preparing a marketing application can be a daunting, resource-intensive process....
Sep 30, 20242 min read
What You Need to Know About eCTD 4.0
Introduction The electronic Common Technical Document (eCTD) has been a cornerstone for regulatory submissions in the pharma and biotech...
Sep 17, 20243 min read
Is It Time to Break Up with Your CRO? 4 Telltale Signs
In the complex world of pharmaceutical development, your relationship with your Contract Research Organization (CRO) can make or break...
Aug 21, 20242 min read
What is a US Agent, and How Do I Know if I Need One?
Navigating the regulatory landscape of the U.S. pharmaceutical market can be complex, especially for foreign manufacturers looking to...
Aug 16, 20242 min read
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